We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety.

Responsibilities:

Clinical Phase:

  • Lead as a medical monitor/Medical expert
  • Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential.
  • Review and provide feedback on study protocols as needed.
  • Deliver therapeutic area training for all case processing team.
  • May require 24/7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients.
  • Drafting medical monitoring plans (MMP) and ensuring compliance.
  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
  • Make assessments on SUSAR reportability.
  • Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).
  • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.

Post-Marketing (Pharmacovigilance):

  • Lead the medical reviewers
  • Medical review of the ICSRs (Spontaneous, literature)
  • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
  • Mentor junior medical reviewers and perform additional review of cases to ensure competency.
  • Provide feedback and ongoing workshops to develop the medical reviewers.
  • Participate in audits and inspections as required
  • Ensure understanding of client needs, conventions and ensure expectations are met and exceeded
  • Training and mentoring other team members

Required Education:

MBBS, or MD (Doctor of Medicine)

 

Required Experience :

  • Experience in leading medical review teams
  • Client communications
  • Safety Database experience
  • Minimum 10 years experience working for service providers or pharmaceutical company
  • At least 5-7 years of experience as a Medical Monitor or clinical phase

Required Technical Skills:

  • Microsoft package
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
  • Working knowledge of EDC systems
  • Good Medical knowledge and Pharmacology understanding

Medical Advisor – VAF 173

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